CH(11)03
26 July 2011
Dear Colleague
Update to the Code of Practice and General Directions
Earlier this month, we sent you a new licence which included a revised set of standard licence conditions. The changes consist of:
- a new licence condition, T123, strengthening the HFEA’s multiple births policy
- a change to licence condition T6, reflecting a new policy for the regulation of new processes
- the deletion of some licence conditions, because they:
- are redundant
- are duplicated elsewhere in the Code ,or
- have been converted into guidance in the Code or information on the HFEA website - clarifications and corrections.
We have now incorporated those licence conditions into the Code of Practice (8th edition) and made some changes to guidance and General Directions. The revised Code and General Directions, which I enclose, come into force on 1 October 2011.
Changes to guidance and licence conditions
The following guidance notes in the Code of Practice contain revised guidance:
Guidance note 1: Person responsible
Guidance note 1 has been updated to clarify that a licence holder and the person responsible should be separate individuals. It also includes new guidance on the need for a person responsible to notify the HFEA of any change to his or her professional registration (see 1.1; 1.2 and 1.5). Finally, the guidance note has also been updated to reflect various changes to licence conditions.
Guidance note 7: Multiple births
After careful consideration, the Authority has introduced a new licence condition (T123) requiring centres not to exceed the maximum multiple births rate specified by the HFEA. The guidance note also includes new guidance on double blastocyst transfer (see 7.2).
Guidance note 9: Preimplantation genetic screening (PGS)
The content of former licence condition T90 has been transposed into guidance. The guidance note also includes a section clarifying that the prohibition on sex selection for social reasons applies to preimplantation genetic screening (see 9.1 – 9.3 and 9B). The guidance note has also been updated to reflect changes to licence conditions.
Guidance note 17: Storage of gametes and embryos
The content of former licence condition T84 has been transposed into guidance, with amendments to improve clarity and ensure consistency with guidance elsewhere in the Code (see 17.15).
Guidance note 18: Witnessing and assuring patient and donor identification
The guidance note has been amended to specify that samples of gametes or embryos should be labelled with two or more (rather than one or more) unique identifiers (see 18.21). The guidance note has also been updated to reflect changes to licence conditions.
Guidance note 27: Adverse incidents and General Directions 0011
The guidance note has been amended to clarify that a breach of confidentiality counts as an adverse incident (this change has also been reflected in General Directions 0011). The guidance note also provides new guidance on informing patients of any adverse incidents which may have resulted in harm to themselves, their gametes or their embryos (see 27.1 and 27.9).
Changes to licence conditions
The following guidance notes in the Code of Practice contain only licence condition changes and minor corrections. No changes to guidance have been made.
Guidance note 32 – Obligations and reporting requirements of centres
The HFEA has recently viewed the process for obtaining approval to carry out new processes. The new policy is reflected in a change to licence condition T6.
From October 2011, the list of ‘licensable activities’ on a licence will only include activities directly referred to in the Act (eg, the creation of embryos; the storage of sperm). It will no longer list processes used to carry out licensable activities (eg, IVF or assisted hatching).
As a consequence of this change, centres will no longer need to apply for a licence variation to carry out a process for the first time. Instead, the centre will only need to apply to carry out a novel process (one which has never been carried out in the UK). Processes which have been approved will be listed on the HFEA website and can be carried out by any licensed centre, provided that it notifies us of its intention to do so.
Details of the application and notification process will be set out in a revised General Directions 0008, which will be published in September 2011.
The remaining guidance notes which contain only licence condition changes are:
3: Counselling
6: Legal parenthood
10: Embryo testing and sex selection
11: Donor recruitment, assessment and screening
15: Procuring, processing and transporting gametes and embryos
20: Donor assisted conception
21: Intra-cytoplasmic sperm injection (ICSI)
22: Research and training
23: The quality management system
24: Third Party agreements
25: Premises and facilities
30: Confidentiality and privacy
The revised Code of Practice and General Directions, hard copies of which are enclosed, will come into force on 1 October 2011. Shortly before 1 October, please remove the outdated guidance notes and insert the new ones, as instructed in the accompanying leaflet. We have provided copies of the entire guidance notes (rather than individual sheets with changes) to minimise the risk of errors when updating your paper copies.
If you have questions about the new Code of Practice or General Directions, please contact your Inspector in the first instance, or email: code8@hfea.gov.uk
Yours sincerely
Professor Lisa Jardine CBE
Chair, Human Fertilisation and Embryology Authority
Page last updated: 17 August 2012